J45
Conditions
Interventions
Group 1: Volunteers with asthma who meet the eligibility criteria.
During the 12-week study phase, patients will visit their appropriate center initially (Visit 1) and at least 12 weeks after Visit 1
Sponsors
Bosch Healthcare Solutions GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: - Patients of either gender aged 18-75 years (inclusive) - Written informed consent - Diagnosis of asthma in the opinion of the investigator (see rational) for at least 6 months prior to visit 1 - Patients capable to use a smart phone and a digital device - Patients owning a smartphone and willing to use it for trial purposes (installing and using the device related free-of-charge App, sending recorded data to PI via E-mail).
Exclusion criteria
Exclusion criteria: - Treatment with systemic corticosteroids and/or hospitalization for asthma exacerbation within the past 14 days prior to visit 1 - Significant, non-reversible, active pulmonary disease (e.g., COPD, cystic fibrosis, bronchiectasis, tuberculosis) - Subjects suffering from acute upper or lower respiratory infection including common cold, influenza, or pneumonia. - Current smokers - Severe acute concomitant diseases during the previous 14 days prior to visit 1 - Active SARS-CoV-2 infection confirmed by positive PCR test within the past 4 weeks prior to V1 - Simultaneous participation in an investigational clinical trial - Family relationship with operators or study personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No formal hypothesis, as this is a hypothesis generating study. Patient and device characteristics are only reported in descriptive measures to develop a hypothesis for a planned confirmatory study. | — |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed